SIMETHICONE 125MG GAS RELIEF- simethicone 125 mg capsule, liquid filled

Simethicone 125MG Gas Relief by

Drug Labeling and Warnings

Simethicone 125MG Gas Relief by is a Otc medication manufactured, distributed, or labeled by One2Zee Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each softgel)

Simethicone 125 mg

PURPOSE

Purpose

Antigas

INDICATIONS & USAGE

Use for the relief of

• pressure
• bloating
• fullness
• commonly referred to as gas

Warning

Keep out of reach of children

Directions

• adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

• store at controlled room temperature 20°-25°C (68°-77°F)
• protact from light, heat and moisture
• do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, titanium dioxide

QUESTIONS

Questions or comments?
Call 1-833-663-2933

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 125MG GAS RELIEF 
simethicone 125 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55629-021
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	Z25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55629-021-01	365 in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	09/11/2024

Labeler - One2Zee Limited Liability Company (078656111)